Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Early Inhospital Thrombolysis With Metalyse

NCT ID: NCT02194153

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 351 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2001-05-31

Brief Summary

Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse® in a real life setting outside clinical trials.

Conditions

Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Metalyse

Metalyse weight-adjusted

Metalyse weight-adjusted

Intervention Type: DRUG

Interventions

Metalyse weight-adjusted

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female patient with suspected myocardial infarction, e.g. during transportation to the hospital by ambulance. No patient younger than 18 years.
• Possibility of obtaining relevant information concerning indication or contraindication of thrombolysis in each patient
• Typical chest pain with a duration of more than 30 minutes
• Definite infarction signs in a 12-lead-ECG with ST-elevation > 0.1 millivolt (mV) in > 2 leads or recent left bundle branch block with typical clinical signs
• Symptom onset <= 6 hours

Exclusion Criteria

• Patients older than 75 years (exception: patients appear much younger)
• Low body weight
• No persons under 18
• contraindications according to summary of product characteristics (SPC) for Metalyse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1123.16

Identifier Type: -

Identifier Source: org_study_id